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510(k) Data Aggregation

    K Number
    K251943

    Validate with FDA (Live)

    Device Name
    Spineology Navigation Instruments
    Manufacturer
    Spineology, Inc.
    Date Cleared
    2025-12-04

    (163 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Special
    Panel
    Orthopedic
    Age Range
    All
    Reference & Predicate Devices
    K170011,K213876
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Spineology Navigation Instruments are indicated for use during the preparation and placement of:

    • Spineology's Fortress, Threshold, Threshold V2, and Palisade pedicle screws
    • Spineology's OptiMesh® Portal Assembly

    during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous orthopedic procedures.

    These instruments are designed for use with the Medtronic StealthStation® Spine System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy.

    Device Description

    Spineology Navigation Instruments are non-sterile, reusable surgical instruments that are manufactured from stainless steel and operated manually.

    Spineology Navigation Instruments for Pedicular Fixation include Awls, Bone Taps, Drills, and Screwdrivers. The navigable instruments are equipped with a dimensional feature that allows connection to Medtronic's NavLock Trackers. A Navigation Adapter is also available with dimensional features that allows the same instruments to connect to Medtronic's SureTrak™ II Universal Trackers. These instruments are compatible with Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems and Medtronic's StealthStation® S7 (v2.1.0) and S8 (v1.0.0) Spine System.

    Spineology Navigation Instruments for Portal Placement include a Dilator, Portal, Tightener, Wrench, and a Portal Surrogate. The navigable instruments are equipped with dimensional features that allow connection to Medtronic's SureTrak II Universal Trackers. These instruments are compatible with Spineology's OptiMesh Expandable Interbody Fusion System for Access Portal Placement and Medtronic's StealthStation® S8 (v1.2.0) Spine System. The navigable Dilator instrument is also equipped with a dimensional feature that allows connection to Medtronic's NavLock Tracker arrays.

    Spineology Navigation Instruments are intended to be used during the preparation and placement of spinal implants in optically navigated procedures

    AI/ML Overview

    N/A

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